Strattera(Atomoxetine) for the Treatment of Attention Disorders in Individuals With Traumatic Brain Injury

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Englewood,
Colorado80113

Purpose:

Atomoxetine is the only medication that is currently approved by the FDA for the treatment
of attention deficit hyperactivity disorder in adults. It has gained recent interest as an
alternative medication for treating attentional problems related to traumatic brain injury
(TBI), but it's effectiveness in this population has not been studied. There are a number
of advantages of Atomoxetine over traditional neuro-stimulant medications currently used for
attentional disorders after traumatic brain injury. This study will use a randomized
double-blind placebo-controlled crossover design to investigate the efficacy of atomoxetine
to improve attention, behavioral function, and depression in adults with TBI

Criteria:

Inclusion Criteria:
- History of TBI
- Moderate to severe TBI as indicated by GCS score of 12 or less; or PTA of seven days
or more
- at least one year post injury
- between the ages of 18-65 (inclusive)
- symptoms consistent with attentional dysfunction
- consent to participate in study
Exclusion Criteria:
- history of any conditions that would prohibit standard neuropsychological testing
- non-English speaking (to the extent that would limit ability to complete study
measures)
- prior history of significant psychiatric illness requiring hospitalization
- epilepsy
- cardiovascular disease or risks including: dysrhythmias, angina, myocardial
infarction, uncontrolled hypertension, valvular heart disease including mitral valve
prolapse
- use of any monoamine axidase inhibitor or any other drug affecting brain monoamine
concentrations
- severe renal or hepatic impairment
- pregnant or lactating

NCT ID:

NCT00702364

Primary Contact:

Principal InvestigatorDavid L Ripley, MDCraig Hospital

Backup Contact:

N/A

Location Contact:

Englewood, Colorado 80113United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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